Status:
COMPLETED
EXOMIND (BTL-699-2) for Improvement of Mental Well-being
Lead Sponsor:
BTL Industries Ltd.
Conditions:
Well-Being, Psychological
Eligibility:
All Genders
22+ years
Phase:
NA
Brief Summary
The goal of this clinical trial is to evaluate if the treatment with EXOMIND (BTL-699-2) device is able to improve mental well-being in adults above the age of 22 years. The main question it aims to a...
Detailed Description
The study uses a multi-center, single-arm, open-label, interventional study design. The subjects will be enrolled and assigned to one experimental study arm. All enrolled participants will receive fou...
Eligibility Criteria
Inclusion
- Age \> 22 years
- Ability to determine the motor threshold of the participant. The participant's motor threshold could be established as the minimum stimulus required to induce contraction of the right thumb
- Subjects willing and able to abstain from partaking in any treatments other than the pre-procedure therapy regime for the improvement of mental well-being, including non-invasive brain stimulation treatments other than the study procedure during study participation
- Willingness to comply with study instructions and to return to the clinic for the required visits
- Women of child-bearing potential\* are required to use birth control measures during the whole duration of the study
- If applicable, subjects will be maintained on pre-study psychotherapeutic regime, and neuropsychiatric prescribed medications (including SSRI or other medication) at a stable therapeutic dosage for at least 2 months prior to study entry
Exclusion
- Electronic implants (Implanted stimulator devices in or near the head - rTMS devices are contraindicated for use in patients who have active or inactive implants (including device leads), deep brain stimulators, cochlear implants, ocular implant, and vagus nerve stimulators, implanted devices such as cardiac pacemakers, defibrillators, neurostimulators. Contraindicated use could result in serious injury or death.
- Metallic, conductive, ferromagnetic or other magnetic sensitive implants/objects in the head or within 30 cm of the treatment coil (examples include implanted electrodes/stimulators, aneurysm clips or coils, stents, bullet fragments, jewelry and hair barrettes) with some exceptions in the mouth as standard amalgam dental fillings, single post dental implants, and dental bridge work. Failure to follow this restriction could result in serious injury or death.
- Drug pump(s)
- Application in the heart area
- Persons with a tendency to seizure (hypotonic, epileptic), or a personal history of epilepsy
- Ongoing anticoagulation therapy
- Ongoing severe or life-threatening condition
- Pulmonary insufficiency
- Heart disorders
- Renal insufficiency
- Decompensated\* hemorrhagic conditions, blood coagulation disorders, cardiovascular diseases
- Malignant or benign tumor
- Fever
- Ongoing pregnancy or nursing
- Ongoing intake disorders such as bulimia or anorexia
- Diagnosis of post-traumatic stress disorder, psychotic disorder or current psychotic symptoms, bipolar disorder, obsessive-compulsive disorder, borderline personality disorder
- Personal history of syncope (except the reflex syncope)
- Vascular, traumatic, tumoral, infectious, or metabolic lesion of the brain, even without a history of seizure, and without anticonvulsant medication
- Withdrawal from one of the following drugs could form a relative hazard for the application of rTMS due to the resulting significant seizure threshold lowering potential: (e.g. alcohol, barbiturates, benzodiazepines, meprobamate, chloralhydrate etc.)
- Systemic infection
- Patients with a broad range of neuropsychiatric diseases are at elevated risk for seizures. Essentially all neurologic conditions with structural cerebral damage (e.g. stroke, multiple sclerosis, traumatic brain injury, Alzheimer's and other neurodegenerative diseases, meningoencephalitis or intracerebral abscess, parenchymal or leptomeningeal cancers)
- History of hyponatremia, hypocalcemia, hypomagnesemia, hypoglycemia, hyperglycemia, renal failure/uremia, liver failure
- History of tendency for raised blood concentrations of pro-convulsant medications due to reduced clearance
- Immunosuppressive therapy with cyclosporine, tacrolimus and other agents that can cause the posterior reversible leukoencephalopathy syndrome
- The use of methamphetamine, barbiturates, cocaine metabolites, opiates and phencyclidine 72 hours before the therapy
- Contradictions for the testing used in the trial, for example, the motor threshold cannot be found or quantified.
Key Trial Info
Start Date :
July 8 2024
Trial Type :
INTERVENTIONAL
Allocation :
ACTUAL
End Date :
February 3 2025
Estimated Enrollment :
38 Patients enrolled
Trial Details
Trial ID
NCT06899646
Start Date
July 8 2024
End Date
February 3 2025
Last Update
July 21 2025
Active Locations (3)
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1
Contour Medical
Gilbert, Arizona, United States, 85296
2
Luxury Psychiatry Medical and Spa
Winter Garden, Florida, United States, 34787
3
Yael Halaas, M.D., F.A.C.S.
New York, New York, United States, 10022